Catheter introducer assembly having safety shielded needle

ABSTRACT

An intravenous catheter introducer assembly having a safety feature to prevent accidental needle sticks. The introducer assembly includes a needle assembly having a groove disposed on its outer surface. The introducer includes a protector made of a hollow member having an open distal end and a inwardly disposed resilient flange disposed thereon. The protector is coaxially slidably disposed around the needle with the flange abutting the outer surface of the needle and adapted to engage the groove when a catheter assembly is removed from the needle assembly.

FIELD OF THE INVENTION

The present invention relates, in general, to intravenous (IV) cathetersand, more particularly, to a safety IV catheter with a needle tipprotector that will automatically cover the needle tip upon needlewithdrawal.

BACKGROUND OF THE INVENTION

An intravenous (IV) catheter is an instrument that is used to introducecertain fluids such as saline solution directly into the bloodstream ofa patient. Typically, a needle or other stylet is first introducedthrough the cannula portion of the catheter and into the skin of thepatient at the desired location such as the back of the patient's handor a vessel on the inside of the arm. Once insertion is complete, theneedle is removed from the cannula portion of the catheter. Afterremoving the needle, a fluid handling device such as a syringe isattached to the luer fitting located at the proximal end of the catheterhub. Fluid then flows directly from the fluid handling device throughthe catheter into the bloodstream of the patient.

When the needle is removed from the cannula, the health care worker mustplace the exposed needle tip at a nearby location while simultaneouslyaddressing the task required to accomplish the needle removal. It is atthis juncture that the exposed needle tip creates a danger of anaccidental needle stick occurring which leaves the health care workervulnerable to the transmission of various, dangerous blood-bornepathogens such as human immune virus (HIV) and hepatitis.

The risk of a contaminated needle stick is not just isolated to thehealth care worker inserting the intravenous catheter. Careless disposalof used needles can put other health care workers at risk as well. Evenothers outside the health care profession, for example those involved inthe clean-up and final disposal of medical waste, are at risk of anaccidental needle stick from a carelessly discarded needle.

The danger to health care workers and others outside the health careprofession from accidental needle sticks has yielded the development ofcatheters with safety mechanisms in which the occurrence of suchaccidental needle sticks is prevented. An example of a catheter having asafety mechanism is disclosed in U.S. Pat. No. Re. 34,416 issued toLemieux. A safety catheter is described which includes an element thatcovers the needle tip upon removal of the needle from the catheter. Thesafety element includes a split flange at its proximal end which isexpanded by the needle as the needle is inserted into an undersized holeat the center of this flange. The safety element is thus held securewithin the catheter hub by inserting the needle through the undersizedhole which forces the outside perimeter of the split flange against theinside wall of the catheter hub. One of the drawbacks to this design isthe amount of friction force exerted against the needle by the splitflange. A tight fit of the flange against the catheter wall causes greatfriction against the needle making it difficult to be withdrawn from thecatheter by the clinician. A lose fit leaves the flange prone toreleasing prematurely from the catheter as the needle is withdrawn,creating the potential that the needle tip will be left exposed.

Another example of a catheter having a safety mechanism is disclosed inU.S. Pat. No. 6,117,108 issued to Woehr et al. A safety IV catheter isdescribed including a resilient needle guard which protects the needletip upon removal of the needle from the catheter hub. The needle guardincludes an arm that includes an opening through which a needle passescausing axial movement of the arm. This axial movement forces the arminto a groove or behind a rib located on the inside of the catheter hub,capturing the needle guard in the catheter hub. A potential issue withthis design develops when the needle guard is not properly seated intothe catheter hub. If the distal end of the needle guard arm is not inalignment with the groove in the catheter hub, excessive forces areplaced on the needle causing a high drag force as the clinician removesthe needle. And, since the needle guard arm is not properly seated inthe groove, it may prematurely release from the catheter hub upon theremoval of the needle leaving the needle tip exposed.

The prior art safety catheters all exhibit one or more drawbacks thathave thus far limited their usefulness and full acceptance byhealth-care workers. What is needed therefore is a safety IV catheterthat functions reliably, is easy and inexpensive to manufacture, andeasy to use.

SUMMARY OF THE INVENTION

An intravenous catheter introducer assembly having a safety feature toprevent accidental needle sticks. The introducer assembly includes aneedle assembly having an elongated hollow tubular needle with aproximal end attached to a catheter hub and a distal end extendingtherefrom. The needle has a groove disposed on its outer surface. Theintroducer includes a protector made of a hollow member having an opendistal end and a inwardly disposed resilient flange disposed thereon.The protector is coaxially slidably disposed around the needle with theflange abutting the outer surface of the needle. The introducer alsoincludes a catheter assembly having an elongated hollow tubular catheterwith a proximal end attached to a catheter hub and a distal endextending therefrom. The catheter is coaxially disposed about theneedle. The catheter hub has a retainer for keeping the protector withinthe catheter hub until the catheter assembly and needle assembly areseparated wherein the flange engages the groove and secures theprotector to the needle such that the open distal end of the protectoris distal to the distal end of the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. The invention itself, however, both as toorganization and methods of operation, together with further objects andadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is a perspective view of the catheter and needle assembly of thepresent invention.

FIG. 2 is an exploded perspective view of the catheter assembly andneedle assembly including the needle tip protector of the presentinvention

FIG. 3 is a perspective view of the needle tip protector of the presentinvention;

FIG. 4 is a view of FIG. 3 taken along line 4—4 illustrating the tab ofthe present invention.

FIG. 5 is a section view of the catheter assembly and needle assemblytaken along line 5—5 of FIG. 1.

FIG. 6 is a perspective view of the needle tip protector with the needleinserted therethrough shown prior to locking the protector over theneedle tip.

FIG. 7 is a perspective view of the needle tip protector shown as lockedonto the needle after removal from the catheter hub and illustrating theneedle tip covered by the protector.

FIG. 8 is a perspective view of an alternate embodiment of the needletip protector.

FIG. 9 is a side view of another alternate embodiment of the needle tipprotector shown as removed from the catheter hub and illustrating theneedle tip covered by the protector.

FIG. 10 is a cross-sectional view taken along line 10—10 of FIG. 9showing the clip which locks the needle tip protector over the needletip.

FIG. 11 is a perspective view of another alternate embodiment of theneedle tip protector shown with the needle inserted therethrough.

FIG. 12 is a side view of another alternate embodiment of a non-circularneedle tip protector which illustrates the needle tip covered by theprotector.

FIG. 13 is a cross-sectional view taken along line 13—13 of FIG. 12 ofthe non-circular needle and needle tip protector.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the term “proximal” refers to a location on the catheterand needle assembly with needle tip protector closest to the clinicianusing the device and thus furthest from the patient on which the deviceis used. Conversely, the term “distal” refers to a location farthestfrom the clinician and closest to the patient.

As illustrated in FIGS. 1 and 2, IV catheter assembly 20 comprisescatheter assembly 22 and needle assembly 24. Needle assembly 24 furtherincludes protector 26. Catheter assembly 22 includes catheter 28 whichis a tubular structure having a proximal end 31 and distal end 29.Proximal end 31 of catheter 28 is fixedly attached to catheter hub 30.Catheters are well known in the medical art and one of many suitablematerials, most of which are flexible thermoplastics, may be selectedfor use in catheter 28. Such materials may include, for example,polyurethane or fluorinated ethylene propylene. Catheter hub 30 is agenerally tubular structure having an internal cavity in fluidcommunication with the internal lumen of catheter 28. Catheter hub 30may be made from a suitable, rigid medical grade thermoplastic such as,for example, polypropylene or polycarbonate. For illustration purposescatheter hub 30 is shown translucent, though in actual use it may betranslucent or opaque. At the proximal end of catheter hub 30 isintegrally attached Luer fitting 32, commonly known in the medical art.Luer fitting 32 provides for secure, leak proof attachment of tubing,syringes, or any of many other medical devices used to infuse orwithdraw fluids through catheter assembly 22. As shown in FIGS. 1, 2,and 5, retainer 60, which is located approximately mid way between theproximal end and distal end of sidewall 36 and fixedly attached theretoas at shoulder 34, includes aperture 62 which is an openingtherethrough. Retainer 60 is generally a doughnut shaped washer made ofa material such as, for example, silicone or any other flexible materialknown to those skilled in the art. As will be described in more detaillater, retainer 60 plays an important role in securing protector 26 incatheter hub 30.

Referring again to FIGS. 1 and 2, needle assembly 24 comprises needle38, which is a tubular structure with proximal end 39 and distal end 41,needle hub 40, and protector 26. Protector 26 is assembled slidably onneedle 38. Needle 38 which is preferably made of stainless steel has alumen therethrough created by its inner diameter. Proximal end 39 ofneedle 38 is fixedly attached to needle hub 40. Bevel 42 which islocated at distal end 41 of needle 38 creates a sharp piercing tip.Needle groove 44, which includes proximal wall 43 and distal wall 45, islocated at distal end 41 of needle 38 proximal to bevel 42 and issmaller in diameter than the nominal outer diameter of needle 38. Needlegroove 44 can be created by any number of means known to those skilledin the art. One such method is by machine grinding around the outsidediameter of needle 38 resulting in an annular channel between itsnominal outer diameter and inner diameter. Machine grinding is a processwell known in the metal forming art. The resulting groove 44 is smallerin dimension than the nominal outer diameter of needle 38 but greater indimension that the lumen in needle 38 and is important in preventing thecomplete removal of protector 26 from needle 38, as will be described inmore detail later. In the preferred embodiment, the dimension acrossgroove 44 is 0.002-0.003 inches smaller than the dimension of thenominal outer diameter of needle 38, dependent upon needle “gauge” size.

Needle hub 40 is generally a tubular structure having an internal cavityin fluid communication with the lumen in needle 38. It is preferablymade of a translucent or transparent generally rigid thermoplasticmaterial such as, for example, polycarbonate. At the most proximal endof the internal cavity in needle hub 40 is fixedly attached porous plug46. A flashback chamber 48 is created in the cavity distal to porousplug 46. Porous plug 46 contains a plurality of microscopic openingswhich are large enough to permit the passage of air and other gasses butsmall enough to prevent the passage of blood. Flashback chamber 48 fillswith blood upon successful entry of the needle tip into the targetedvein, providing the clinician visual conformation of the correctplacement of the needle.

Referring now to FIGS. 3 and 4, protector 26 has a proximal end 49 and adistal end 50 and is preferably a hollow tubular structure with cavity72 therethrough formed from a single piece of thin, resilient materialsuch as, for example, stainless steel or a polymer. Located distal toproximal end 49 of protector 26 is resilient flange 70. Flange 70includes a proximal wall and a distal wall. The longitudinal width offlange 70, the distance between the proximal wall and the distal wall,is less than the longitudinal width of needle groove 44 and is importantin preventing the complete removal of protector 26 from needle 38, aswill be described in more detail later. As shown in FIG. 4, resilientflange 70 is biased into cavity 72 of protector 26 resulting indimension “a” which, when the flange 70 is in its relaxed unrestrainedcondition, is less than the nominal outer diameter of needle 38,permitting for a very close but slidable fit of protector 26 over needle38.

Referring now to FIGS. 5-7, it can understood how protector 26 isassembled to needle 38. The proximal end of needle 38 is fixedlyattached to the distal end of needle hub 40, which contains porous plug46 fixedly attached to its proximal end. The distal end of needle 38 isinserted through proximal end 49 of protector 26 and then advancedthrough cavity 72, moving from proximal to distal. Flange 70 is flexed,as a result of its resilient property, so that needle 38 will passthrough cavity 72 of protector 26. Needle groove 44 is located at thedistal end of needle 38 just proximal to bevel 42. Groove 44 decreasesthe diameter of needle 38 locally to a dimension smaller than thenominal outer diameter of needle 38. When needle 38 is retracted, flange70 locks into groove 44 preventing the complete removal of protector 26from the distal end of needle 38.

As shown in FIG. 1, needle assembly 24, including protector 26, isassembled into catheter assembly 22. Distal end 41 of needle 38 extendsdistally from distal end 29 of catheter 28. Protector 26 is held distalto retainer 60 inside the cavity in catheter hub 30 by aperture 62,which has a diameter smaller in dimension than the outer diameter ofprotector 26. Protector 26 is also located proximal to catheter 28,which has an inner diameter smaller than the outer diameter of protector26 preventing any further distal movement. Needle assembly 22 is securedonto luer fitting 32 of catheter hub 30.

Now, it will be described how in actual clinical use, the IV catheterassembly 20 of the present invention functions. The distal end of needle38 which extends just past the distal end of catheter 28 is insertedinto the patient's vein. The clinician observes blood in the flashchamber in needle hub 40. The clinician grasps needle hub 40, andcatheter assembly 22 alone is moved distally into the vein. Theclinician applies slight pressure to the insertion site to hold catheterassembly 22 secure. The clinician grasps needle hub 40 and beginswithdrawal of needle assembly 24 from catheter assembly 22. During thisprocess, protector 26 remains secure inside catheter hub 30 until groove44 on needle 38 comes into contact with flange 70. Prior to groove 44encountering flange 70, retainer 60 blocks any further proximal movementof protector 26. During withdrawal, needle 38 is retracted proximallyinto catheter 28 and catheter hub 30. When groove 44 of needle 38 comesinto contact with flange 70 of protector 26, the distance betweenproximal wall 71 and distal wall 73 of flange 70 which is less than thedistance between proximal wall 43 and distal wall 45 of groove 44 causesflange 70 which is biased into cavity 72 to engage into groove 44 thuslocking protector 26 on needle 38. After flange 70 locks into groove 44,continued proximal movement of needle 38 carries protector 26 proximalas well, forcing proximal end 49 of protector 26 against retainer 60.When enough force is applied by protector 26, aperture 62 dilates due tothe resilient property of retainer 60, permitting continued movementproximal, past retainer 60. Needle assembly 24 is now removed entirelyfrom catheter assembly 22, with the needle tip covered by protector 26of the present invention.

A first alternate embodiment of the present invention is shown in FIG.8. In this embodiment, protector 126, similar to protector 26, isgenerally hollow tubular structure formed from a single piece of thin,resilient material such as, for example, stainless steel or a polymer.This embodiment has a plurality of flanges 170. Flanges 170 are locateddistal to proximal end 149 of protector 126. Flanges 170 create proximalwalls 171 and distal walls 173 and are biased into cavity 172 ofprotector 126.

A second alternate embodiment of the present invention is shown in FIG.9. In this embodiment, protector 226, similar to protector 26, includesclip 270. Clip 270, which functions to replace flange 70 in thepreferred embodiment, is slidably assembled to protector 226. Clip 270is preferably made of a resilient material such as, for example,stainless steel, or any other suitable material known to those skilledin the art. As shown in FIG. 10, clip 270 is generally a U-shapedwireform secured to protector 226 by bridges 264 and 266.

FIG. 11 shows a third alternate embodiment where protector 326 is ahollow tubular structure preferably formed from a single piece of thin,resilient material such as for example, stainless steel or a polymer. Inthis embodiment, protector 326 has a flat formed on one side along itsentire length. Located distal to proximal end 349 of protector 326 isflange 370, similar to flange 70. Needle notch 344, which functions toreplace needle groove 44, is an indentation in needle 338. In thisembodiment, the depth from surface 347 of needle notch 344 to the outersurface of needle 338 is 0.002-0.003 inches, dependent upon needle“gauge” size. However, the depth from surface 347 of needle notch 344 tothe outer surface of needle 338 could be larger than 0.003 inchespossibly exposing the lumen of needle 338. Needle notch 344 locks withflange 370 preventing the complete removal of protector 326 from distalend 341 of needle 338. To ensure the alignment of flange 370 with notch344, needle 338 also has a flat along its entire length which takes theshape of protector 326 to prevent any axial movement of needle 338 inprotector 326. Needle notch 344 could be a single indentation in needle338 or multiple indentations possibly spaced 180° apart. Similarly,protector 326 could contain a single flange or multiple flanges possiblyspaced 180° apart.

FIGS. 12 and 13 shows a fourth alternate embodiment of the presentinvention. In this embodiment, protector 426 is a hollow non-circulartubular structure preferably formed from a single piece of thin,resilient material such as, for example, stainless steel or a polymer.Located distal to proximal end 449 of protector 426 is flange 470,similar to flange 370. Needle notch 444, similar to notch 344, functionsto replace needle groove 44. Needle notch 444 is an indentation inneedle 438 which locks with flange 470 preventing the complete removalof protector 426 from distal end 441 of needle 438. In this embodiment,the depth from surface 447 of needle notch 444 to the outer surface ofneedle 438 is 0.002-0.003 inches, dependent upon needle “gauge” size.However, the depth from surface 447 of needle notch 444 to the outersurface of needle 438 could be larger than 0.003 inches possiblyexposing the lumen of needle 438. To ensure the alignment of flange 470with notch 444, needle 438 is also non-circular taking the shape ofprotector 426 to prevent any axial movement of needle 438 in protector426. Needle notch 444 could be a single indentation in needle 438 ormultiple indentations possibly spaced 180° apart. Similarly, protector426 could contain a single flange or multiple flanges possibly spaced180° apart.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. Accordingly, it isintended that the invention be limited only by the spirit and scope ofthe appended claims. In addition, it should be understood that everystructure described above has a function and such structure can bereferred to as a means for performing that function.

What is claimed is:
 1. An intravenous catheter introducer assemblyhaving a safety feature to prevent accidental needle sticks, saidintroducer assembly comprising: a. a needle assembly comprising anelongated hollow tubular needle having a proximal end attached to aneedle hub, a distal end extending therefrom, and a lumen runningtherebetween, said needle having a groove disposed on an outer surfacethereof between said distal and proximal ends, the outer surface of theneedle immediately proximal to the groove having a first diameter, theouter surface of the needle immediately distal to the groove having asecond diameter substantially equal to the first diameter; b. aprotector comprising a hollow member having an open distal end and aninwardly disposed resilient flange disposed thereon, said protector iscoaxially slidably disposed around said needle with said flange abuttingsaid outer surface of said needle; and c. a catheter assembly comprisingan elongated hollow tubular catheter having a proximal end attached to acatheter hub and a distal end extending therefrom, said cathetercoaxially disposed about said needle, said catheter hub having aretainer for keeping said protector within said catheter hub until saidcatheter assembly and needle assembly are separated wherein said flangeengages said groove and secures said protector to said needle such thatsaid open distal end of said protector is distal to said distal end ofsaid needle.
 2. The introducer assembly of claim 1 wherein saidprotector comprises a cylindrical tubular member having open proximaland distal ends and an inwardly disposed flange disposed therebetween.3. The introducer assembly of claim 1 wherein said protector comprises acylindrical tubular member having open proximal and distal ends having aplurality of inwardly disposed flanges disposed therebetween.
 4. Theintroducer assembly of claim 3 wherein said plurality of inwardlydisposed flanges are arranged concentrically about said protector. 5.The introducer assembly of claim 1 wherein said needle and saidprotector have non-circular cross sections such that said protectorcannot rotate with respect to said needle.
 6. The introducer assembly ofclaim 1 wherein said groove on said needle is a concentric grooverunning around a circumference of said needle without penetrating intosaid lumen.
 7. The introducer assembly of claim 1 wherein said groove onsaid needle comprises a notch cut into said needle exposing said lumen.8. The introducer assembly of claim 1 wherein the needle is cylindrical.9. The introducer assembly of claim 1, the flange being defined by anintegral portion of the protector member.
 10. An intravenous catheterintroducer assembly having a safety feature to present accidental needlesticks, said introducer assembly comprising: a. a needle assemblycomprising an elongated hollow tubular needle having a proximal endattached to a needle hub, a distal end extending therefrom, and a lumenrunning therebetween, said needle having a groove disposed on an outersurface thereof between said distal and proximal ends; b. a protectorcomprising a hollow member having an open distal end and an inwardlydisposed resilient flange disposed thereon, said protector is coaxiallyslidably disposed around said needle with said flange abutting saidouter surface of said needle; and c. a cathether assembly comprising anelongated hollow tubular catheter having a proximal end attached to acatheter hub and a distal end extending therefrom, said cathetercoaxially disposed about said needle, said catheter hub having aretainer for keeping said protector within said catheter hub until saidcatheter assembly and needle assembly are separated, said retainerhaving a resilient washer disposed concentrically within said catheterhub and fixedly attached thereto, said washer having an insider diameterless than an outside diameter of said protector, wherein said flangeengages said groove and secures said protector to said needle such thatsaid open distal end of said protector is distal to said distal end ofsaid needle.
 11. The introducer assembly of claim 10, wherein saidneedle is cylindrical.
 12. An intravenous catheter introducer assemblyhaving a safety feature to prevent accidental needle sticks, saidintroducer assembly comprising: a. a needle assembly comprising anelongated hollow tubular needle having a proximal end attached to aneedle hub, a distal end extending therefrom, and a lumen runningtherebetween, said needle having a groove disposed on an outer surfacethereof between said distal and proximal ends; b. a protector comprisinga hollow member having an open distal end and an inwardly disposedresilient flange disposed thereon, said protector is coaxially slidablydisposed around said needle with said flange abutting said outer surfaceof said needle, the protector having a constant inner diameter betweensaid distal end and a proximal end thereof; and c. a catheter assemblycomprising an elongated hollow tubular catheter having a proximal endattached to a catheter hub and a distal end extending therefrom, saidcatheter coaxially disposed about said needle, said catheter hub havinga retainer for keeping said protector within said catheter hub untilsaid catheter assembly and needle assembly are separated wherein saidflange engages said groove and secures said protector to said needlesuch that said open distal end of said protector is distal to saiddistal end of said needle.
 13. The introducer assembly of claim 12wherein said protector comprises a cylindrical tubular member havingopen proximal and distal ends and an inwardly disposed flange disposedtherebetween.
 14. The introducer assembly of claim 12 wherein saidprotector comprises a cylindrical tubular member having open proximaland distal ends having a plurality of inwardly disposed flanges disposedtherebetween.
 15. The introducer assembly of claim 14 wherein saidplurality of inwardly disposed flanges are arranged concentrically aboutsaid protector.
 16. The introducer assembly of claim 12 wherein saidneedle and said protector have non-circular cross sections such thatsaid protector cannot rotate with respect to said needle.
 17. Theintroducer assembly of claim 12 wherein said groove on said needle is aconcentric groove running around a circumference of said needle withoutpenetrating into said lumen.
 18. The introducer assembly of claim 12wherein said groove on said needle comprises a notch cut into saidneedle exposing said lumen.
 19. The introducer assembly of claim 12, theflange being defined by an integral portion of the protector member. 20.The introducer assembly of claim 12 wherein the needle is cylindrical.21. An intravenous catheter introducer assembly having a safety featureto prevent accidental needle sticks, said introducer assemblycomprising: a. a needle assembly comprising an elongated hollow tubularneedle having a proximal end attached to a needle hub, a distal endextending therefrom, and a lumen running therebetween, said needlehaving a groove disposed on an outer surface thereof between said distaland proximal ends; b. a protector comprising a hollow member having anopen distal end and an inwardly disposed resilient flange disposedthereon and extending longitudinally of the member, said protector iscoaxially slidably disposed around said needle with said flange abuttingsaid outer surface of said needle; and c. a catheter assembly comprisingan elongated hollow tubular catheter having a proximal end attached to acatheter hub and a distal end extending therefrom, said cathetercoaxially disposed about said needle, said catheter hub having aretainer for keeping said protector within said catheter hub until saidcatheter assembly and needle assembly are separated wherein said flangeengages said groove and secures said protector to said needle such thatsaid open distal end of said protector is distal to said distal end ofsaid needle.
 22. The introducer assembly of claim 21 wherein saidprotector comprises a cylindrical tubular member having open proximaland distal ends and an inwardly disposed flange disposed therebetween.23. The introducer assembly of claim 21 wherein said protector comprisesa cylindrical tubular member having open proximal and distal ends havinga plurality of inwardly disposed flanges disposed therebetween.
 24. Theintroducer assembly of claim 23 wherein said plurality of inwardlydisposed flanges are arranged concentrically about said protector. 25.The introducer assembly of claim 21 wherein said needle and saidprotector have non-circular cross sections such that said protectorcannot rotate with respect to said needle.
 26. The introducer assemblyof claim 21 wherein said groove on said needle is a concentric grooverunning around a circumference of said needle without penetrating intosaid lumen.
 27. The introducer assembly of claim 21 wherein said grooveon said needle comprises a notch cut into said needle exposing saidlumen.
 28. The introducer assembly of claim 21, the flange being definedby an integral portion of the protector member.
 29. The introducerassembly of claim 21, wherein the needle is cylindrical.